Explanatory Memorandum to COM(2011)593 - Basic safety standards for protection against the dangers arising from exposure to ionising radiation - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2011)593 - Basic safety standards for protection against the dangers arising from exposure to ionising radiation. |
|---|---|
| source | COM(2011)593  |
| date | 29-09-2011 |
Exposure to ionising radiation results in a health detriment. In normal situations doses are very low so that there is no clinically observable tissue effect, but there still is a possible late effect, cancer in particular. It is assumed that there is no dose threshold for this effect: any exposure, however small, can be the cause of cancer later in life. It is further assumed that the probability of occurrence of a late effect is proportional to the dose. This calls for a specific approach in radiation protection based on the three principles of justification, optimisation and dose limitation, which are the cornerstones of the system of protection established many decades ago by the International Commission on Radiological Protection (ICRP).
Euratom legislation has always followed the recommendations of the ICRP. This highly respected scientific organisation has recently issued new guidance on the system of radiation protection (Publication 103, 2007). While preserving the three pillars of the system, the ICRP sets out in more detail the application of the principles throughout any exposure situation and irrespective whether the source of radiation is man-made or natural. Radiation protection indeed covers not only exposures resulting from the operation of radiation sources (planned exposure situations), but also emergency exposure situations, for instance resulting from a nuclear accident, and a range of other situations, in particular those involving exposure to natural radiation sources, termed ‘existing exposure situations’. The ICRP has also updated the methodology for assessment of the effective dose as well as the application of dose limits, in the light of the latest scientific information.
A large proportion of workers in industries processing naturally occurring radioactive materials (NORM) receive doses above the dose limit for members of the public, but still do not benefit from protection as occupationally exposed workers. This anomaly is not sustainable, so the ICRP’s new Recommendations aim to integrate natural radiation sources within the overall system. Already in 1996, the current Euratom legislation i had introduced requirements for work activities involving natural radiation sources. These were put together in a separate Title rather than being integrated within the overall radiation protection framework. In addition, maximum flexibility was offered to Member States to decide for instance which NORM industries were of concern. This has led to wide differences in controlling NORM industries and in protecting workers in these industries. This situation is not compatible with Euratom’s role in setting uniform standards.
Exposure to indoor radon, a natural radioactive noble gas entering dwellings from the soil below, is far more important than exposure from any other radiation source. Recent epidemiological studies have confirmed that lung cancer may be caused by exposure to radon, and WHO i now ranks this as a major health issue i. Exposure to radon in dwellings was addressed in 1990 in a Commission Recommendation. The confirmed causation of lung cancer by exposure to radon calls for strengthening radon mitigation policies in Europe through binding requirements. Radioactivity in building materials has been included in the Construction Products Directive i, but this has still not led to any corresponding standards being adopted by the European Committee for Standardisation (CEN). The revision of the Basic Safety Standards (BSS) Directive will not only address the recycling of residues from NORM industries into building materials, but also ensure coherent and harmonised protection against other building materials with enhanced levels of radioactivity.
In addition to the health protection of people, the ICRP radiation protection system now addresses the protection of biota against exposure to ionising radiation. While it is generally assumed that the exposure of biota does not call for additional measures, this assumption now needs to be demonstrated through compliance with criteria and on the basis of an agreed methodology.
There is a significant body of Euratom legislation addressing different radiation protection issues defined as basic safety standards in the Euratom Treaty. As these issues have developed over a long period of time, there are inevitably quite a few inconsistencies between different acts and also obsolete references as a result of updated legislation. These inconsistencies need to be resolved, in line with the Commission’s policy for simplification of European legislation.
The problem can be summarised as follows:
- Scientific progress is not fully reflected in present legislation;
- There are inconsistencies between the existing pieces of legislation;
- The scope of the present legislation does not fully cover natural radiation sources or the protection of the environment.
This translates into four specific objectives:
- to introduce the necessary subject-matter amendments in order to respond to the latest scientific data and operational experience,
- to clarify the requirements and to ensure coherence within the body of European legislation,
- to ensure coherence with the international recommendations,
- to cover the whole range of exposure situations and categories of exposure.
According to Article 2(b) of the Euratom Treaty ‘… the Community shall, as provided in this Treaty … establish uniform safety standards to protect the health of workers and of the general public and ensure that they are applied’. Accordingly, in the Treaty’s preamble, the Member States declare that they are ‘resolved to create the conditions necessary for the development of a strong nuclear industry’ and also ‘anxious to create conditions of safety necessary to eliminate hazards to the life and health of the public’. Euratom is mandated to ‘establish uniform safety standards to protect the health of workers and of the general public and ensure that they are applied.’ Therefore, Euratom’s competence to regulate in the field of health protection against ionising radiation is explicitly recognised by the Euratom Treaty.
The exclusive nature of Euratom’s legislative powers under Articles 30 and 31 of the Euratom Treaty does not in principle require the application of the principle of subsidiarity. These Articles require the Commission to seek for its legislative proposals the opinion of a Group of Experts designated by the Euratom Scientific and Technical Committee.
Following the entry into force of the Euratom Treaty, a comprehensive set of legislation establishing basic safety standards has been enacted on the basis of Article 31 of the Treaty.
The main pillar of that legislation is Council Directive 96/29/Euratom laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation (Euratom BSS Directive). Further legislation based on Article 31 of the Euratom Treaty comprises:
- Council Decision 87/600/Euratom of 14 December 1987 on Community arrangements for early exchange of information in the event of a radiological emergency;
- Council Regulation 3954/87/Euratom of 22 December 1987 laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency and the related legislative acts, Commission Regulation 944/89/Euratom of 12 April 1989 laying down maximum permitted levels of radioactive contamination in minor foodstuffs following a nuclear accident or any other case of radiological emergency, and Commission Regulation 770/90/Euratom of 29 March 1990 laying down maximum permitted levels of radioactive contamination of feedingstuffs following a nuclear accident or any other case of radiological emergency i;
- Council Directive 89/618/Euratom of 27 November 1989 on informing the general public about health protection measures to be applied and steps to be taken in the event of a radiological emergency (Public Information Directive);
- Commission Recommendation 90/143/Euratom of 21 February 1990 on the protection of the public against indoor exposure to radon;
- Council Directive 90/641/Euratom of 4 December 1990 on the operational protection of outside workers exposed to the risk of ionising radiation during their activities in controlled areas (Outside Workers Directive);
- Council Regulation 1493/93/Euratom of 8 June 1993 on shipments of radioactive substances between Member States;
- Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure, repealing Directive 84/466/Euratom of 3 September 1984 (Medical Directive);
- Commission Recommendation 2001/928/Euratom of 20 December 2001 on the protection of the public against exposure to radon in drinking water supplies;
- Council Directive 2003/122/Euratom of 22 December 2003 on the control of high-activity sealed radioactive sources and orphan sources (HASS Directive);
- Council Directive 2006/117 of 20 November 2006 on the supervision and control of shipments of radioactive waste and spent fuel;
- Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations.
The BSS Directive have been regularly updated in 1962, 1966, 1976, 1980, 1984 and 1996, taking account of advances in scientific knowledge of the effects of ionising radiation in line with the recommendations of the ICRP and on the basis of operational experience. Medical exposures have been included in specific legislation since 1984. Specific problem areas are covered in three ‘associated directives’ – the High-Activity Sealed Radioactive Sources (HASS) Directive, the Outside Workers Directive and the Public Information Directive. An analysis of the legislation enacted under Article 31 of the Euratom Treaty reveals that the Medical Directive, the HASS Directive, the Outside Workers Directive and the Public Information Directive are closely linked with BSS Directive 96/29, in that they develop further the requirements of the BSS Directive or refer to different provisions of the BSS Directive. For this reason the proposal for a new basic safety standard Directive will cover the subject matter and scope of these Directives.
The Commission will propose separately a Directive laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption (COM(2011)385). This Euratom Directive will replace an existing Directive 98/83/EC with regard to its application to radioactive substances and complement it with technical annexes on sampling frequencies, methods of analysis and detection levels. The substance matter of this Directive is such that it could be incorporated in a recast with the basic safety standards at an appropriate point in time. At this stage however, since the Directive is intended to merely transpose existing requirements under EC Treaty legislation, in such a way as to avoid any interpretation as to a possible change in substance, it is considered more appropriate not to incorporate it at this stage in a proposal for a revised Basic Safety Standards Directive. In addition, at the time the Article 31 Group of Experts gave its opinion on the revised Basic safety standards Directive, there was still discussion whether a Directive on radioactive substances in water intended for human consumption should be based on Euratom Treaty or EC Treaty. In these circumstances it was decided to proceed with the proposal for a revised Basic Safety Standards Directive as agreed upon in February 2010 by Article 31 Group of Experts.
The other legislation based on Article 31 of the Euratom Treaty, as discussed in the Impact Assessment Report, either uses a different instrument, or the scope is essentially outside radiation protection or the legislation is specific to certain types of installation.
In 2005 the European Commission published ‘Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment: the better regulation initiative’ (COM/2005/535 final) as a response to the European Parliament’s and Council’s requests to simplify EU legislation and enhance its quality. This initiative is the basis for attempting the consolidation of the five Directives mentioned above. It is neither feasible nor useful to recast these Directives with the other pieces of legislation under Title II, Chapter 3 of the Euratom Treaty.
The International Basic Safety Standards reflect an international consensus on what constitutes a high level of safety for protecting people and the environment from the harmful effects of ionising radiation. They are approved by the IAEA Board of Governors and are non-binding in nature. The main document on radiation protection is Safety Standards No 115 ‘International Basic Safety Standards for Protection against Ionising Radiation and for the Safety of Radiation Sources’, IAEA, 1996. In 2006, the IAEA, together with other international organisations (FAO, ILO, the NEA/OECD, PAHO and WHO), embarked upon the revision of Safety Standards No 115. This ongoing activity is also driven by the new ICRP Recommendations in Publication 103, published in 2007.
The European Commission has cooperated closely with the IAEA and other international organisations on the revision of the International Basic Safety Standards. However, it should be emphasised that the Euratom Basic Safety Standards Directive is not a means to confer legally binding status on the international requirements. There are two main reasons why referring to or incorporating the international BSS in European legislation is not feasible. On the one hand, the language of the international BSS does not conform to EU legal drafting rules. The international requirements are also sometimes far too detailed and go beyond the idea of ‘basic’ standards in the Euratom Treaty. The requirements of the Euratom BSS also need to take into account internal market rules. On the other hand, the international BSS allow for the fact that countries throughout the world, with different levels of regulatory and technological infrastructure, must be able to comply with them. The European legislation is more ambitious. Euratom is bound by the Treaty to establish uniform basic safety standards. Incorporating the international BSS in a European act is hence not only difficult, but would also be at odds with the major role played by Euratom since 1959 and the significant body of legislation that has already been built up. Nevertheless, the Commission pursues the largest possible coherence between Euratom and international standards, and envisages the eventual sponsorship of the latter on behalf of Euratom.
The Commission (DG ENER) has initiated and supported several projects and studies on specific radiation protection issues, the results of which have been published in the Radiation Protection Series of the European Commission i. The various projects, studies and conferences identify challenges to the implementation of the current radiation protection legislation and problem areas that are not sufficiently covered by the current system of protection.
In 2009, the Commission launched a consultation on a ‘proposal for new requirements on natural radiation sources in the Basic Safety Standards Directive’. The Working Party ‘Natural Sources’ of the Article 31 Group of Experts proposed a comprehensive approach to the regulation of NORM industries, radon and building materials. This document was published on the Commission website and was also highlighted on the EANNORM website i. The consultation ran from 02 February 2009 to 20 April 2009.
The revision of the Euratom Basic Safety Standards has benefited from continuous interaction with two organisations representing major stakeholders, namely the Heads of European Radiological Protection Competent Authorities (HERCA) and the International Radiation Protection Association (IRPA). An outline of the revision of the BSS was presented to HERCA at meetings in December 2008 and 2009 as well as in June 2010. The response of the radiation protection authorities was positive, and HERCA did not raise any important issue calling for changes in the approach. The revision has been presented at the International IRPA Congress (Buenos Aires 2008) and at European congresses organised by IRPA (Brasov, 2006, Helsinki 2010) as well as at annual meetings of the European IRPA societies. The European IRPA branch has set up a working party to collect input from their societies on the ongoing revision of both the international and Euratom BSS. There was also regular contact with the European Atomic Forum (FORATOM) which represents the stakeholders from the nuclear industry.
The key interaction with stakeholders is through the Article 31 Group of Experts, i.e. the experts to be consulted under Article 31 of the Euratom Treaty. In February 2010, the Group of Experts issued an opinion on the possible revision of European legislation in the form of a draft Directive. This text is the fruit of intensive work by the working parties of the Group of Experts, taking into account the studies conducted by the Commission as well as other sources of information (conferences, networks).
The draft proposed by the Commission is to a large extent the same as the draft on which the Article 31 Group of Experts' Opinion was based. Only some editorial corrections have been made and a few definitions added. The Experts left it for the Commission to decide whether the definition of HASS sources should remain the same as in the current Directive 2003/122/Euratom or whether the definition should be aligned with the IAEA Code of Conduct on the safety and security of radioactive sources. The Commission has opted for the latter.
In its Opinion the Article 31 Group of Experts also suggests maintaining the text of Article 54 of Directive 96/29/Euratom, which allows Member States to opt out from the uniform Basic Safety Standards and introduce stricter dose limits to reflect possible new scientific findings after the adoption of the directive. This would jeopardise the implementation of the Euratom Treaty which requires establishment of uniform standards. The proposed text of the directive therefore does not include such clause. In its judgement of 25 November 1992 in the case Commission of the European Communities v Kingdom of Belgium (Case C-376/90 i), the Court stated that 'in the absence of an express provision to the contrary, the Directive must be interpreted as allowing the Member States to set, …, stricter dose limits'. In this respect, an explicit statement on the uniformity of the standards has been introduced in the proposed text of the revised Basic Safety Standards Directive.
A comprehensive impact assessment was made to evaluate the possible options for reaching the objectives:
1. to bring the health protection of workers, the public and patients in line with latest scientific data and operational experience,
2. to streamline existing EU legislation in the field of radiation protection,
3. to ensure coherence with international standards and recommendations,
4. to cover the whole range of exposure situations, including exposure to natural radiation sources at home, as well as the protection of the environment.
In the light of these objectives, the impact assessment report considers a broad range of options both with regard to the extent of the consolidation with other legislation and with regard to scope and substance of the incorporated legislation:
Option 1: Maintaining the status quo of existing legislation.
Option 2: Revision of Basic Safety Standards and Medical Directive. This option envisages changes in the two Directives with the aim to align them with the latest ICRP recommendations and with the advance of the scientific knowledge.
Option 3: Revision and consolidation of Basic Safety Standards and Medical Directive, and integration of the Outside Workers Directive, the Public Information Directive and the High Activity Sealed Sources Directive. Non-legislative measures will address natural radiation issues and the protection of non-human species. This option offers a revision of the Basic Safety Standards Directive by extending the requirements to medical exposure, public information, outside workers exposure and high-activity sealed sources. Within this policy option, the BSS Directive 96/29 and the related legislative acts (Medical Directive 97/43/Euratom, Outside Workers Directive 90/641/Euratom, HASS Directive 2003/122/Euratom, Public Information Directive 89/618/Euratom, Commission Recommendation 90/143/Euratom) will merge and the requirements of BSS Directive and of Medical Directive will at the same time be upgraded to the latest scientific knowledge and regulatory experience.
Option 4: Revision of the Basic Safety Standards Directive and broadening the scope to cover exposure to natural radiation at home. With this option, a comprehensive approach to the management of exposures due to natural radiation sources will be incorporated within the overall set of requirements of the Euratom BSS. The requirements will reflect the distinction between planned and existing exposure situations, as made in ICRP Publication 103. While occupational exposure to natural radiation sources (as well as public exposure from residues or effluents from NORM industries) is already considered in Options 1 to 3, the exposures to natural radiation sources that will explicitly be incorporated relate to public exposure in the domestic environment.
Option 5: Revision of the Basic Safety Standards Directive and broadening the scope to cover protection of non-human species. The subject matter and general purpose of the BSS Directive 96/29/Euratom is the health protection of the population and workers against dangers of ionising radiation. This Directive applies to the protection of the human environment, but only as a pathway from environmental sources to the exposure of man. In line with the new ICRP Recommendations, it will be complemented with specific consideration of the exposure of biota in the environment as a whole. The aim would be to require Member States to consider suitable protection of non-human species in their radiation protection legislation.
Option 6: Revision and consolidation of the Basic Safety Standards Directive and Medical Directive, integration of the Outside Workers Directive, the Public Information Directive and the High Activity Sealed Sources Directive, and broadening the scope to cover public exposure to natural radiation and protection of non-human species. This option includes all the elements of Option 3 (revision of the Basic Safety Standards Directive and integration of the other four Directives). The revision of the Basic Safety Standards includes all identified issues, and broadens the scope to include the whole range of exposure situations, including indoor public exposure to radon and to building materials, and all categories of human and non-human exposures.
The effectiveness of the proposed options is assessed towards the objectives, the efficiency of the additional requirements in terms of their health and environmental impact, economic benefit and administrative cost, and the coherence of the Directive with overall Euratom and EU legislation. The amendments to the Basic Safety Standards and to the Medical Directive will have an important impact in the following areas:
- Social and health impact: The social impact relates to providing adequate protection to workers in NORM industries. The health impact will be most noticeable with regard to medical exposures, in particular in preventing unnecessarily frequent or high-dose radiological examinations (for instance CT scans) of patients leading to increased cancer incidence in future. Specific professional groups (for instance cardiologists) will benefit from the reduction of the dose limit for the lens of the eye and avoid contracting radiation-induced cataract.
- Economic impact: While it is not possible at this stage to make a quantified economic assessment, NORM industries will benefit from the harmonisation of requirements between Member States.
- Administrative cost: While the principle of protection optimisation, calling for doses to be ‘as low as reasonably achievable’ (ALARA), taking social and economic factors into account, is key to ensuring a proper cost-benefit balance in operational radiation protection, the new concept of a ‘graded approach’ extends this principle to enhance the effectiveness of regulatory oversight and reduce the administrative cost to industries.
Additional amendments introduced in the three other Directives are the following:
- harmonisation of the definition of high-activity sealed radioactive sources (HASS) with the international standards;
- specific requirements for the protection of outside workers with a clear definition of the responsibilities of their employers and the undertakings conducting the practices in which they are exposed;
- requirements for informing the public before and during an emergency, within the overall revised scope for the management of emergency exposure situations.
Merging the five Directives is a major achievement in terms of the coherence of Euratom legislation. The restructuring required to accommodate this broader scope of the BSS Directive further improves the clarity of the text and ensures better operational implementation of the requirements.
The broader scope of the new Directive entails further substantial amendments:
With regard to ‘existing exposure situations’, reference levels are given for indoor radon concentrations and for external exposure from building materials. Member States will be required to establish a comprehensive and transparent Radon Action Plan, adjusted to national needs and to the geological features of different regions. Harmonised requirements for building materials will permit further standardisation under the Construction Products Directive (Council Directive 89/106/EEC). While consumers and the building professions will benefit from the monitoring and labelling of materials, the administrative burden on industry will be kept to a minimum by the proper choice of reference levels and the list of types of materials deemed to be of concern.
Relevant requirements in the Euratom BSS for the protection of non-human species will allow Member States to incorporate this in national environmental policies, in a way which is coherent with current approaches to health protection against ionising radiation. The environmental impact assessment of these new requirements relates essentially to the prevention of environmental damage in case of an accident. For the normal operation of an installation it is rather a demonstration that there is no impact to the environment.
Contents
- Legal elements of the proposal
- Budgetary implications
- 1.1. Background and objectives
- 1.2. Subsidiarity
- 1.3. Current legislation
- 1.4. Simplification
- 1.5. International context
- 2. Consultation of interested parties and impact assessment
- 2.1. Interested parties
- 2.2. Impact assessment
- 3.1. Chapter I: Subject matter and scope
- 3.2. Chapter II: Definitions
- 3.3. Chapter III: System of radiation protection
- 3.4. Chapter IV: Requirements for radiation protection education, training and information
- 3.5. Chapter V: Justification and regulatory control of practices
- 3.6. Chapter VI: Protection of workers, apprentices and students
- 3.7. Chapter VII: Protection of patients and other individuals subjected to medical exposure
- 3.8. Chapter VIII: Protection of members of the public
- 3.9. Chapter IX: Protection of the environment
- 3.10. Chapter X: Requirements for regulatory control
- 3.11. Chapter XI: Final provisions
The recast of five Directives yields a voluminous single Directive, with over 100 articles and numerous annexes. In view of the extent and complexity of the changes, a formal recast procedure is not pursued. It is not possible to point to each and every element of the proposal. The following sections give a summary description of the main features of each chapter.
This chapter defines the scope of the new Directive (general purpose of the Directive across different categories of exposure and different exposure situations and specific purposes resulting from integration of the requirements for high-activity sealed radioactive sources and for public information, and the exclusion of non-controllable exposures). The scope is broadened to include the exposure of space crew to cosmic radiation, domestic exposure to radon gas in indoor air, external exposure to gamma radiation from building materials, and the protection of the environment beyond environmental pathways leading to human exposure.
This chapter includes all definitions given in the earlier Directives, with some adjustments to resolve inconsistencies as well as to adjust to the new terminology introduced in ICRP Publication 103 and in the draft International Basic Safety Standards.
This title includes the general principles of radiation protection: justification, optimisation and dose limitation. It explains the more prominent role of dose constraints and reference levels in the process of optimisation, with Annex I giving the bands of reference levels proposed by the ICRP for existing and emergency exposure situations. The dose limits are not modified, except for a uniform definition of the annual occupational dose limit (no averaging over 5 years) and a lower organ dose limit for the lens of the eye, as recommended by the ICRP. The new Directive no longer includes the technical measurements entering into the definition of the effective dose and other factors entering into the assessment of doses, but refers to ICRP Publication 103 for this purpose. In addition, the Directive no longer includes the long lists of radionuclide-specific dose coefficients (doses per unit intake by ingestion or inhalation), but will refer to a forthcoming consolidated publication of the ICRP which can be downloaded free of charge.
This chapter brings together the miscellaneous requirements governing education and training in the different Directives and includes provisions for recognition of the ‘Radiation Protection Expert’ and ‘Medical Physics Expert’.
The application of the principle of justification remains a national responsibility. Specific attention is given to the justification of practices involving the deliberate exposure of humans for non-medical imaging (e.g. security screening in airports).
The regime for regulatory control is now presented as a three-tier system (notification, registration, licensing), replacing the earlier two-tier system of reporting and ‘prior authorisation’. A more detailed list of which types of practice are subject to either registration or licensing is given. As part of the concept of a ‘graded approach’ to regulatory control, there is explicit provision for the specific exemption of practices (from notification and from authorisation) at national level. The default values for exemption on the basis of activity concentrations are now taken from IAEA Safety Guide RS-G-1.7. The same default values apply to release from regulatory control (clearance levels), but allow for specific values in European guidance. Member States will be allowed to keep default clearance levels in current national legislation, and to keep the existing exemption values for moderate amounts of material. Details of exemption criteria and exemption and clearance levels are given in Annex VI.
This chapter also includes more precise requirements on the information to be provided with a licence application (the issuing of discharge authorisations for radioactive airborne or liquid effluent is covered in Chapter VIII).
This title includes, with little amendment, the provisions on occupational exposure in Directive 96/29/Euratom. It also includes the specific requirements in the Outside Workers Directive, and introduces a clear allocation of responsibilities between the employer and the undertaking where the practice is conducted. The data system for individual radiological monitoring of exposed workers and the minimum set of data to be communicated for outside workers has been updated in the light of recommendations by HERCA.
No distinction is made between the management of occupational exposures in NORM industries and other practices, but the former will benefit from a graded regulatory approach on the basis of prevailing exposures and their potential to increase with time.
This chapter now covers occupational exposure in all exposure situations, which provides more explicit protection for emergency workers as well as for workers exposed to high levels of indoor radon in their workplace.
This chapter includes the relevant requirements from the Medical Directive, but strengthens them, in particular with regard to:
- the application of the justification principle;
- information to patients on the health risks and benefits;
- information on doses;
- diagnostic reference levels;
- involvement of the Medical Physics Expert;
- prevention of accidental and unintended medical exposures.
This chapter includes the public exposure requirements in Directive 96/29/Euratom, with more explicit consideration of the issuing of discharge authorisations for radioactive effluent (also with reference to Commission Recommendation 2004/2/Euratom).
The section on emergency exposure situations includes the requirements of the Public Information Directive.
The section on existing exposure situations addresses indoor exposure to radon, with a somewhat lower maximum reference level for existing dwellings than in Commission Recommendation 90/143/Euratom, in line with ICRP and WHO recommendations. It also includes requirements for the classification of building materials on the basis of a radioactivity index and a uniform reference level for the annual dose resulting from residence in a building constructed with such materials.
This chapter, in line with the broader scope of the Directive as in the International Basic Safety Standards, aims to provide a means to demonstrate compliance with environmental criteria. While the ICRP has published a methodology for dose assessment for biota, a publication on the application of criteria is still awaited. Pending such further guidance, it is up to national authorities to assess the doses to representative animals and plants in terms of protection of the ecosystem.
Appropriate technical measures also need to be taken to avoid the environmental consequences of an accidental release and to monitor existing levels of radioactivity in the environment, from the perspectives of both environmental protection and human health.
This chapter includes all the responsibilities of the regulatory authorities in all exposure situations. A clear structure is provided by the following sections:
- Institutional infrastructure;
- Control of sealed radioactive sources (with Annexes II, XII, XIII, XIV, XV incorporating different aspects of the Directive on High-Activity Sealed Radioactive Sources);
- Orphan sources (with new requirements with regard to metal contamination);
- Emergency exposure situations (establishment of an emergency management system and international cooperation, while requirements for the protection of workers and members of the public in an emergency exposure situation are addressed in Chapters V and VIII, respectively);
- Existing exposure situations (general provisions for the management of contaminated areas, radon action plan);
- System of enforcement (inspection programme and response to deficiencies).
The first section on ‘institutional infrastructure’ calls for a clear definition of the responsibilities of different authorities. The Commission is to receive periodically updated information and publish this in the Official Journal. This section also defines the responsibilities of the ‘Radiation Protection Expert’, the ‘Radiation Protection Officer’ (in the current BSS these concepts were merged within the function of ‘Qualified Expert’) and the ‘Medical Physics Expert’.
The transposition of the new Directive into national law should not require a major legislative effort, so a 2-year transposition deadline is deemed sufficient. Specific new features, such as the protection of the environment, can be transposed later.
In line with the Euratom Treaty, the Basic Standards are to be uniformly applied in the Member States, though without prejudice to those requirements for which flexibility is clear from the wording of the text. However, dose limits, default exemption values, the reference level for building materials, etc. are explicitly intended for uniform transposition and application.
There are no implications for the EU budget.